Subclinical Hypothyroidism and Normogonadotropic Anovulation

Completed

• Conditions: Polycystic Ovary Syndrome; Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)
• Interventions: Other: Comparison of laboratory test results in women in the 4 study arms

• Registration Number: NCT05782725
• Lead Sponsor: Jagiellonian University

Brief Summary

Thyroid hormones (TH) can modify the functioning of the hypothalamic-pituitary-ovarian axis, affecting the functions of granulosa cells and the development and apoptosis of preantral follicles. TH receptors are present within the oocytes, and TH and anti-thyroid antibodies (ATA) are present in the follicular fluid. Improper thyroid function can cause ovulation disorders, luteal phase failure, impaired endometrial receptivity and result in implantation failures and recurrent miscarriages. While overt hypothyroidism is treated to improve fertility, the effect of subclinical hypothyroidism (SCH) and the presence of circulating ATAs on fertility and obstetric outcomes is uncertain and data on ovarian reserve rates are conflicting. Among the causes of ovulation disorders (group II according to the WHO classification), polycystic ovary syndrome (PCOS) dominates, found in 3-15% of women of reproductive age, and the remaining group of causes is the so-called Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD). The exact etiology of both entities is unknown.

Detailed Description

Purpose of the study

Evaluation of ovarian reserve indices in women with normogonadotropic anovulation with SCH and without thyroid disease.

Detailed objectives

i) Assessment of AMH, FSH, LH, estradiol, astral follicle count (AFC)/ovarian volume in the subpopulation of women with PCOS and SCH compared to women with PCOS without thyroid disease ii) Assessment of AMH, FSH, LH, estradiol, AFC/ovarian volume in the subpopulation of women with HPOD (other than PCOS) with SCH compared to women with HPOD without thyroid disease iii) Comparison of AMH, FSH, LH, estradiol, AFC/ovarian volume in women with PCOS and HPOD with and without thyroid disease and evaluation of correlation with US ovarian morphology iv) Calculation of the cut-off point of AMH concentration correlating with a high probability of PCOS diagnosis and TSH correlating with unfavorable parameters of ovarian function/HPO axis.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-11
• Study First Posted: 2023-03-23
• Primary Completion: 2023-12-01
• Study Completion: 2024-01-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• age 18-45
• irregular periods
• infertility due to ovulation disorders
• euthyreosis

Exclusion Criteria

• diagnosed and treated thyroid dysfunction,
• history of thyroidectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
4	Comparison of laboratory test results in women in the 4 study arms	HPOD without SCH
1	Comparison of laboratory test results in women in the 4 study arms	PCOS and SCH
2	Comparison of laboratory test results in women in the 4 study arms	PCOH without SCH
3	Comparison of laboratory test results in women in the 4 study arms	HPOD and SCH

Primary Outcome Measures

Name	Time	Method
Blood serum AMH concentration	01.07.2022-01.12.2023	Measurement of serum AMH concentration in women in 4 arms of the study

Secondary Outcome Measures

Name	Time	Method
Blood serum FSH, LH, estradiol	01.07.2022-01.12.2023	Measurement of serum FSH, LH, estradiol concentration in women in 4 arms of the study
AFC/ovarian volume	01.07.2022-01.12.2023	Ultrasound measurement of AFC/ovarian volume

Trial Locations

Locations (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics; 🇵🇱 Krakow, Poland